Resources
The Biomedical Alliance in Europe feedback to the European public Consultation on cross-border activities of associations
The Biomedical Alliance in Europe (BioMed Alliance) welcomes the efforts of the European Commission to ensure a full single market freedoms for associations, simplifying their cross-EU activities and...
BioMed Alliance joins broad group of health stakeholders in welcoming & providing recommendations on EHDS
On 20 October, BioMed Alliance joined a group of 29 stakeholders in welcoming the European Commission’s proposal on the European Health Data Space (EHDS). The stakeholders, which include medical pro...
New survey looks into issues around the limited availability of medical devices
BioMed Alliance has published an important new survey on the availability of medical devices, assessing if clinicians experience that any devices that they normally use are no longer available on the...
BioMed Alliance shares views of medical societies in EHDS consultation
The BioMed Alliance replied to the consultation on the proposal for the European Health Data Space (EHDS), welcoming the proposal but also highlighting a series of key considerations that should be ta...
BioMed Alliance article on the implications of IVDR for innovation in diagnostics in HemaSphere
The BioMed Alliance In Vitro Diagnostics (IVD) Task Force has written an article on the Critical Implications of the In Vitro Diagnostics Regulation (IVDR) for Innovation in Diagnostics, which was pub...
Fill out & Promote our CORE-MD Survey on educational needs in regulatory affairs
The CORE-MD Project has launched a new survey, aiming to assess educational needs of clinicians, notified bodies and regulators related to regulatory affairs. The survey takes around 10-15 minutes t...
Join our joint hybrid workshop on the European Health Data Space Proposal
The European Health Data Space (EHDS) can have a very positive effect on health research, care and innovation but it is necessary that certain barriers are addressed to maximise related opportunities....
Medical societies provide support to those affected by the war in Ukraine
The developments around the Russian army's invasion of Ukraine are a clear violation of international law, and they have already had horrifying consequences and led to a serious humanitarian and healt...
Continuing Medical Education in time of crisis
The BioMed Alliance has published an article in the Journal of European CME entitled ‘Continuing Medical Education (CME) in time of crisis: How medical societies face challenges and adapt to provide...
Useful documents for the IVDR requirements
In-house IVDs (IH-IVDs or often called LDTs) are exempt from most provisions of Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation, IVDR) provided they meet the conditions set ou...
New statement: EHDS, an opportunity to unleash the power of data?
BioMed Alliance has released a new statement ahead of the upcoming European Commission legislative proposal on the European Health Data Space (EHDS). The new EHDS can play a key role in facilitating h...
BioMed Alliance statement highlighting key recommendations for data sharing ahead of EHDS proposal
BioMed Alliance has released a statement in December 2021 ahead of the upcoming European Commission legislative proposal on the European Health Data Space (EHDS). The BioMed Alliance Task Force on Hea...